国: カナダ
言語: 英語
ソース: Health Canada
OLANZAPINE
MINT PHARMACEUTICALS INC
N05AH05
ASENAPINE
5MG
TABLET (ORALLY DISINTEGRATING)
OLANZAPINE 5MG
ORAL
30
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0128783003; AHFS:
APPROVED
2015-02-04
Page 1 of 60 PRODUCT MONOGRAPH PR MINT-OLANZAPINE ODT Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg, 20 m g USP Antipsychotic Agent Mint Pharmaceuticals Inc. Date of Revision: 6575 Davand Drive February 8, 2021 Mississauga, Ontario L5T 2M3 SUBMISSION CONTROL NO: 244805 Page 2 of 60 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ................................................................................3 INDICATIONS AND CLINICAL USE ......................................................................................3 CONTRAINDICATIONS ...........................................................................................................4 WARNINGS AND PRECAUTIONS ..........................................................................................4 ADVERSE REACTIONS ..........................................................................................................14 DRUG INTERACTIONS ..........................................................................................................30 DOSAGE AND ADMINISTRATION ......................................................................................32 OVERDOSAGE ........................................................................................................................33 ACTION AND CLINICAL PHARMACOLOGY ....................................................................34 STORAGE AND STABILITY ..................................................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................37 PART II: SCIENTIFIC INFORMATION ...............................................................................38 PHARMACEUTICAL INFORMATION ..................................................................................38 CLINICAL TRIALS ............................................................................................. 完全なドキュメントを読む